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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT02169856 |
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Date of registration:
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09/06/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Role of Emotional Freedom Techniques in Reducing Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy
EFT |
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Scientific title:
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A Randomized Controlled Trial: Role of EFTs (Emotional Freedom Techniques) in Reducing Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy. |
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Date of first enrolment:
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July 2013 |
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Target sample size:
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50 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT02169856 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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Pakistan
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Contacts
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Name:
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Sheikh F Riaz, FCPS I |
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Address:
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Telephone:
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Email:
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Affiliation:
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Benazir Bhutto Hospital, Rawalpindi |
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Name:
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Jahangir S Khan, FCPS, FACS |
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Address:
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Telephone:
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Email:
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Affiliation:
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Benazir Bhutto Hospital, Rawalpindi |
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Name:
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Muhammad Z Saeed, FCPS I |
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Address:
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Email:
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Affiliation:
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Benazir Bhutto Hospital, Rawalpindi |
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Name:
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Fazal H Shah, FCPS I |
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Address:
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Telephone:
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Email:
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Affiliation:
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Benazir Bhutto Hospital, Rawalpindi |
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Name:
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Aurangzeb Khan, FCPS |
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Address:
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Telephone:
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Email:
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Affiliation:
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Benazir Bhutto Hospital, Rawalpindi |
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Name:
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Muhammad B Habshi, FCPS I |
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Address:
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Telephone:
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Email:
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Affiliation:
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Benazir Bhutto Hospital, Rawalpindi |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Patients undergoing elective laparoscopic cholecystectomy for gallstone disease.
2. Patients with age range of 25 to 55 years
Exclusion Criteria:
1. H/O chronic illness like DM, IHD, CRF, CLD,
2. H/O acute or chronic psychiatric or psychological illness.
3. H/O APD (acid peptic disease) or regurgitation.
4. H/O of any chemotherapy (cancer drugs, opioids), radiotherapy, any history of
repeated infection.
5. H/O use of hepatotoxic drugs like acetaminophen, ciprofloxacin, ATT, valproic acid
etc. in last one month.
6. H/O alcohol intake in last one month.
7. Previous hepatobilliary surgery.
8. Complicated cholecystectomy in which laparoscopic cholecystectomy is converted to
open cholecystectomy.
9. Patients who are given opioids in postoperative period.
10. Patients who need epidural analgesia in postoperative period.
Age minimum:
25 Years
Age maximum:
55 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Postoperative Nausea and Vomiting
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Intervention(s)
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Drug: Sevoflurane 2.5 vol %
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Drug: Inj. Atracurium 0.5 mg/kg
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Drug: Inj. Propofol 2.5mg/kg
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Drug: Tab. Midazolam 7.5 mg
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Behavioral: EFTs (emotional freedom techniques)
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Drug: Inj. Midazolam 0.7mg/kg
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Drug: Drug: Inj. Ketorolac 30 mg IV
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Drug: Inj. Zantac 50mg IV
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Drug: Inj. Cefuroxime 1.5 g IV
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Primary Outcome(s)
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Postoperative nausea and vomiting.
[Time Frame: will be measured at upto 15 hours postoperatively.]
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Rescue antiemetic
[Time Frame: It will be measured upto 15 hours postoperatively.]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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